By David Ikeda, Senior Director of Clinical Operations and Regulatory Strategist, CovarsaDx
By the time an in vitro diagnostic (IVD) reaches the clinical stage, the science is usually solid. The assay performs as expected. The analytical validation is complete. Sensitivity and specificity are dialed in.
But too often, when the focus shifts from bench to bedside, something gets lost in translation.
At CovarsaDx, we see it all the time: tests that are scientifically sound but operationally complicated—where labeling, usability, and site workflow weren’t designed with real users in mind. It’s not because sponsors overlook the importance of these details; it’s because they’re too close to their own product.
When Familiarity Becomes a Blind Spot
Developers know their products better than anyone. That familiarity, however, can create blind spots. What feels intuitive to the design team can be confusing to the clinicians, site staff, or participants running the test.
That’s where clear, well-structured labeling becomes so critical. When sponsors come to us late in the process, we often see protocols or instructions for use (IFUs) that make perfect sense in theory, but not in practice.
That disconnect often shows up when we ask developers to articulate what makes a step “intuitive.” In reality, that intuition comes from hundreds of internal repetitions, not from the design itself. A first-time user, especially one who is sick, stressed, or unfamiliar with diagnostic testing, doesn’t have that mental model to fall back on. Clinical teams see this all the time during usability sessions: steps that feel obvious in the lab become unclear or misinterpreted in real-world settings.
This is precisely why strong, user-focused labeling is not optional; it’s imperative to support safe, consistent use across every experience level.
Labeling Isn’t Just About Words
Labeling isn’t simply a regulatory formality, it’s where the gap between developer intuition and real-world use gets resolved. When instructions don’t align with how users actually move through a test, site staff end up improvising, and that’s when deviations, delays, and data inconsistencies creep in. Regulators notice those patterns, too; unclear labeling is one of the most common contributors to usability-related findings.
At CovarsaDx, we work closely with sponsors to review labeling and study materials before they reach the site level. Even when we’re not involved in upstream human factors engineering, our clinical and regulatory teams help sponsors think through usability from every angle:
- Are the instructions clear to someone encountering the product for the first time?
- Do the steps match the physical and operational flow of the site?
- Are there hidden barriers that could affect compliance or enrollment?
These seem like small questions, but in IVD and medical device trials they often determine whether a study runs smoothly or struggles from the first patient in.
The Cost of Coming in Late
In many cases, CovarsaDx joins a study when labeling, IFUs, and timelines are already finalized. By then, our role becomes reactive—adapting workflows, clarifying site guidance, and troubleshooting issues that could have been avoided.
It’s not an uncommon scenario. Sponsors are often working under compressed schedules, and by the time they engage a CRO, they’re eager to launch. But without the time to pressure-test labeling or site readiness, studies risk unnecessary slowdowns.
Sponsors who involve their CRO early before protocols are locked gain an important advantage. They get outside perspective from a team that understands both the regulatory expectations and the operational realities of running a trial across diverse sites.
Seeing What Sites See
Every study looks tidy in a spreadsheet. Real life is messier.
Our traveling CRAs visit sites every week, seeing firsthand how protocols and instructions play out in practice. They watch the workflow, talk with coordinators, and identify friction points that only become obvious in action.
That constant feedback loop helps sponsors make smarter decisions whether that means clarifying IFU steps, adjusting timelines, or simplifying data collection forms. The goal isn’t just to comply with the protocol, it’s to make sure the protocol can actually be followed.
Lessons Learned and Applied
Not every study goes smoothly. Some of the most valuable lessons come from the ones that test our assumptions.
I think about our work on complex infectious disease studies that required new workflows and extended timelines. They took longer to get off the ground, but the extra preparation paid off. When you take the time to understand how sites function, what their limitations are, and how their staff operate, you design a study that respects their realities and produces better data.
That’s what sponsors pay for when they work with an experienced CRO: not just execution, but foresight.
The Real Measure of Readiness
For sponsors, readiness isn’t just about having an approved protocol. It’s about having a study that sites can run smoothly, that patients can participate in easily, and that regulators can trust.
Every line in a protocol and every word in an IFU should serve that goal. The most successful studies aren’t just scientifically sound, they’re usable.
At CovarsaDx, our job is to make that bridge between innovation and execution seamless, helping sponsors turn great science into great studies.
About the Author
David Ikeda is Senior Director of Clinical Operations and Regulatory Strategist at CovarsaDx. With more than 30 years of experience in IVD clinical research, David specializes in regulatory strategy, protocol design, and operational oversight, helping sponsors navigate the path from concept to clearance with efficiency and confidence.